ACT-293987 in Pulmonary Arterial Hypertension - Full Text View

Purpose

Long-term, single-arm, multicenter, open-label extension, Phase 3 study, to evaluate the safety and tolerability of ACT-293987 in patients with PAH who participated in the double-blind study AC-065A302 (GRIPHON)

Condition	Intervention	Phase
Pulmonary Arterial Hypertension	Drug: ACT-293987	Phase 3

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Long-term Single-arm Open-label Study, to Assess the Safety and Tolerability of ACT-293987 in Patients With Pulmonary Arterial Hypertension

Resource links provided by NLM:

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure

U.S. FDA Resources

Further study details as provided by Actelion:

Primary Outcome Measures:

Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to end of study. The duration of the study will be country-dependent and based on the results of the AC-065A302 study. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	670
Study Start Date:	December 2009
Estimated Study Completion Date:	February 2015
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 ACT-293987, twice daily	Drug: ACT-293987 tablets, twice daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients who have completed the double-blind study AC-065A302 as scheduled per protocol (i.e., treated until unblinding of the study), or who have experienced a clinical worsening of PAH (adjudicated by the CEC) during study AC-065A302.
Signed informed consent

Exclusion Criteria:

Any major violation of protocol AC-065A302.
Females who plan to become pregnant during the study, or are breastfeeding.
Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results, such as drug or alcohol dependence, or psychiatric disease.
Known hypersensitivity to ACT-293987 or any of the excipients.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01112306

Show 156 Study Locations

Sponsors and Collaborators

Actelion

Investigators

Study Director:

Aline Frey

Actelion

More Information

No publications provided

Responsible Party:	Actelion
ClinicalTrials.gov Identifier:	NCT01112306 History of Changes
Other Study ID Numbers:	AC-065A303
Study First Received:	April 8, 2010
Last Updated:	April 25, 2013
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board Belgium: Federal Agency for Medicinal Products and Health Products Belgium: Institutional Review Board Canada: Ethics Review Committee Canada: Health Canada Czech Republic: Ethics Committee Denmark: Danish Medicines Agency Denmark: Ethics Committee France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Institutional Ethical Committee Ireland: Irish Medicines Board Ireland: Research Ethics Committee Israel: Ethics Commission Israel: Ministry of Health Netherlands: Medical Ethics Review Committee (METC) Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Singapore: Domain Specific Review Boards Singapore: Health Sciences Authority Slovakia: State Institute for Drug Control Slovak Republic: Ethics Committee Spain: Comité Ético de Investigación Clínica Spain: Spanish Agency of Medicines Sweden: Medical Products Agency Sweden: Regional Ethical Review Board Taiwan: Department of Health Taiwan: Institutional Review Board Taiwan: National Bureau of Controlled Drugs United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: Research Ethics Committee Australia: Department of Health and Ageing Therapeutic Goods Administration Australia: Human Research Ethics Committee Australia: National Health and Medical Research Council Austria: Federal Office for Safety in Health Care Belarus: Ministry of Health China: Food and Drug Administration Czech Republic: State Institute for Drug Control Germany: Ethics Commission Germany: Federal Institute for Drugs and Medical Devices Greece: Ethics Committee Greece: National Organization of Medicines Hungary: National Institute of Pharmacy Hungary: Research Ethics Medical Committee India: Drugs Controller General of India India: Institutional Review Board Italy: Ethics Committee Italy: The Italian Medicines Agency Malaysia: Ministry of Health Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Romania: Ethics Committee Romania: National Medicines Agency Russia: Ethics Committee Russia: Ministry of Health of the Russian Federation Russia: Pharmacological Committee, Ministry of Health Serbia: Ethics Committee South Korea: Institutional Review Board South Korea: Korea Food and Drug Administration (KFDA) Switzerland: Swissmedic Thailand: Ethical Committee Thailand: Food and Drug Administration Turkey: Ethics Committee Turkey: Ministry of Health Ukraine: Ministry of Health Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by Actelion:

Pulmonary Arterial Hypertension
PAH
Open-label

Additional relevant MeSH terms:

Hypertension, Pulmonary
Hypertension
Lung Diseases

Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013